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NCT ID: NCT02905877 Completed - Clinical trials for Functional Neurological Disorders

The Pathophysiology of Functional Neurological Disorders

Start date: September 2016
Phase:
Study type: Observational

Functional disorders, also called psychogenic or psychosomatic are very common, disabling and their costs to society are immense. Functional movement disorders are abnormal, involuntary movements, that are illogical in terms of classic neurology. Intriguingly, they typically manifest when patients pay attention to them and disappear with distraction. The investigators aim to further the understanding of the pathophysiological mechanisms underlying functional neurological disorders in order to improve treatment. In particular they aim to understand the effect of attention on movement in general, on functional neurological mechanisms and on the sense of agency (of subjective control) over a movement. Patients with a functional neurological disorder, patients with an organic neurological disorder and healthy participants will perform simple tasks, such as reaching to a target, while additional tasks will manipulate their attention. The effects of these attentional manipulations will be analysed on several levels: movement performance, analysed by the kinematics and electromyography (EMG),and psychophysical measures, such as the sense of agency. If the hypothesis turns out to be true, then changing the attentional focus could be used as a treatment in functional neurological disorders.

NCT ID: NCT02905019 Completed - Malaria Clinical Trials

A Safety and Efficacy Study of R21 +/- ChAd63/MVA ME-TRAP

Start date: August 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of adjuvanted R21 alone and in combination with a viral-vectored vaccine regimen (constituting adjuvanted R21 + ChAd63 and MVA encoding ME-TRAP) against malaria sporozoite challenge in healthy malaria-naive volunteers. Healthy adult volunteers will be recruited in London, Oxford and Southampton. All vaccinations will be administered intramuscularly. The study involves having either two, three or five vaccinations and then undergoing challenge infection with malaria, or receiving no vaccinations then undergoing challenge infection with malaria.

NCT ID: NCT02904980 Completed - Clinical trials for Developmental Coordination Disorder

The Effects of a Group-based Gaze Training Intervention for Children With Developmental Coordination Disorder

Start date: February 2015
Phase: N/A
Study type: Interventional

The aim of this study was to integrate a gaze training intervention (i.e., quiet eye training; QET) that has been shown to improve the throwing and catching skill of children with Developmental Coordination Disorder (DCD), within an approach (i.e., group therapy) that might alleviate the psychosocial influence of these motor skill deficits.

NCT ID: NCT02904330 Completed - Graves' Disease Clinical Trials

K1-70 - A Study in Subjects With Graves' Disease

Start date: August 2016
Phase: Phase 1
Study type: Interventional

This study is the first time that K1-70 will be administered to humans. The principal aim of this study is to obtain safety and tolerability data when K1-70 is administered as an IM injection or as an IV infusion to subjects with Graves' disease. Current therapy for Graves' disease includes treatment with anti-thyroid drugs, destruction of the thyroid using radioiodine, or total surgical thyroidectomy. Beta-blockers and calcium antagonists may be used to control some of the symptoms of hyperthyroidism. K1-70 is a thyroid stimulating hormone receptor antagonist that may provide new in vivo diagnostic and therapeutic tools for the management of patients with Graves' disease, patients with thyroid cancer and patients who would benefit from controlling receptor activity.

NCT ID: NCT02903966 Completed - Colitis, Ulcerative Clinical Trials

GSK2982772 Study in Subjects With Ulcerative Colitis

Start date: November 15, 2016
Phase: Phase 2
Study type: Interventional

This study is the first experience with GSK2982772, a receptor-interacting protein-1 (RIP1) kinase inhibitor, in subjects with active ulcerative colitis (UC). The primary objective will be to investigate the safety and tolerability of repeat oral doses of GSK2982772 60 mg or placebo three times daily for 42 days (Part A) followed by open label with GSK298772 60 mg three times daily for 42 days (Part B). In addition to pharmacokinetics (PK), a number of experimental and clinical endpoints will be employed to obtain information on the pharmacodynamics (PD), and preliminary efficacy in subjects with active UC. Although no formal hypothesis will be tested, these endpoints will enable a broader understanding of the mechanism of action and potential for clinical efficacy of GSK2982772 in UC. Within 30 Days of screening visit, subjects will be randomized to receive either GSK2982772 60 mg or placebo orally three times daily for 42 Days (6 weeks) in a 2:1 ratio in Part A study. Subjects who complete the Part A study will move to open label Part B study to receive GSK2982772 60 mg three times daily for an additional 42 Days (6 weeks). After the open label (Part B) treatment period, subjects will enter the Follow-up period which lasts for 28 Days (+/- 3 Days) post the last administration of study medication. The total duration of participation in the study will be approximately 20 Weeks from screening to the last study visit.

NCT ID: NCT02901873 Completed - Thyroidectomy Clinical Trials

EIS in Thyroid and Parathyroid Surgery

Start date: June 27, 2016
Phase: N/A
Study type: Interventional

Parathyroid glands are involved in calcium metabolism and their damage during neck surgery results in 'hypoparathyroidism', a condition characterized by 'low blood calcium' levels; this is associated with significant short and long term morbidity. There are four parathyroid glands in the neck which can vary in size and location. They can be mistaken for lymph nodes, fat or thyroid nodules. A normal parathyroid gland is the size of a small pea and is often difficult to recognize during surgery; making it susceptible to inadvertent injury or removal. Thyroid and parathyroid surgery are commonly performed in the UK. Prompt and accurate identification of parathyroid tissue during surgery reduces the likelihood of hypoparathyroidism. However, this complication is still common. Research exploring the use of intraoperative technologies to enable early identification and preservation of normal parathyroid glands during surgery is ongoing. Electrical impedance spectroscopy (EIS) is one such technology. ZedScanTM is a handheld device that measures electrical impedance of tissues. It is currently used as a adjunct during colposcopy in cervical cancer screening. The device has a CE mark for this purpose and is safe to use in humans. We have already demonstrated that electrical impedance spectroscopy can detect differences in cellular structure and differentiate between tissues in the rabbit neck. We now aim to demonstrate the feasibility of using this technology (ZedScanTM) in humans. This has potential to be used in thyroid and parathyroid surgery to differentiate parathyroid glands from other structures; thereby decreasing their damage and the risk of post surgical hypothyroidism.

NCT ID: NCT02901847 Completed - Clinical trials for Peripheral Arterial Disease

To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities.

PodPAD
Start date: September 2016
Phase: N/A
Study type: Interventional

The aim of the project is to investigate the clinical and patient centred outcomes of people with Peripheral Arterial Disease (PAD) attending a podiatry led integrated care pathway, utilising advice on diet, activity and smoking cessation. The podiatry clinic will be delivered from the Move More centre (NCSEM) and participants will be encouraged to access these facilities as part of their activity programme which will be agreed with the physical activity team. Primary and secondary outcomes will be clinical - claudication pain, distance walked at 3 and 6 months, blood pressure and lipid monitoring, weight management, reduced BMI, and the success of any smoking cessation. Quality of life and patient satisfaction with the programme will also be assessed.

NCT ID: NCT02901080 Completed - Anxiety Clinical Trials

Clinical and Cost Effectiveness of Alpha-Stim AID CES

Start date: August 11, 2016
Phase: N/A
Study type: Interventional

This is a single-centre research study in patients seen within an NHS Improving Access to Psychological Interventions (IAPT) service with suspected generalised anxiety disorder (GAD). The study will involve 120 patients from the Leicestershire and Rutland area in England, United Kingdom. Participants will use the Alpha-Stim AID Cranial Electrotherapy Stimulations (CES) medical device, which is approved for use and proven to be safe and work for the treatment for anxiety, depression and insomnia. Participants will use the Alpha-Stim AID for 60 minutes every day for 6 or 12 weeks, either whilst on the waiting list for standard care treatment from IAPT, or in conjunction with standard care treatment from IAPT. The study will involve 6 study visits - one face-to-face at visit 1, followed by 5 visits via telephone at week 4, 6, 8, 12 and 24. At each visit, participants will be asked to complete questionnaires to assess anxiety, depression, sleep difficulty, quality of life and work and social functioning. The purpose of the study is to gather evidence for the clinical benefits and cost effectiveness of the Alpha-Stim AID when used in an NHS setting - how well does it work, and does it's use result in cost savings for the NHS. The study may show that the Alpha-Stim AID should be available on the NHS for patients with suspected GAD.

NCT ID: NCT02900378 Completed - Clinical trials for Chronic Heart Failure With Reduced Ejection Fraction

randOmized stUdy Using acceleromeTry to Compare Sacubitril/valsarTan and Enalapril in Patients With Heart Failure

OUTSTEP-HF
Start date: December 20, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this randomized, actively controlled, double-blind study with prospective data collection was to assess differences between sacubitril/valsartan versus enalapril in increasing exercise capacity and non-sedentary physical activity in HFrEF patients. Physical activity was assessed by the 6 minute walk test, and daily physical activity was continuously measured by means of a wrist-worn accelerometry device from 2 weeks before until 12 weeks after start of study therapy (sacubitril/valsartan or enalapril).

NCT ID: NCT02900235 Completed - Healthy Clinical Trials

Mass Balance Study of MT-3995

Start date: August 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the absorption, metabolism and excretion of MT-3995 in healthy subjects.